CN116803413A

CN116803413A - Traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome and preparation method and application thereof

Info

Publication number: CN116803413A
Application number: CN202310217517.5A
Authority: CN
Inventors: 王�琦; 郑燕飞; 陈国松; 黄立明; 董丽丹
Original assignee: Shenzhen Shuangbai Kang Pharmaceutical Technology Co ltd
Current assignee: Shenzhen Shuangbai Kang Pharmaceutical Technology Co ltd
Priority date: 2022-08-26
Filing date: 2023-02-28
Publication date: 2023-09-26
Also published as: CN115317550A

Abstract

The invention relates to a traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome, and a preparation method and application thereof, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 2 to 100 parts of bupleurum, 2 to 100 parts of radix trichosanthis, 1 to 80 parts of angelica, 1 to 80 parts of peach kernel, 2 to 120 parts of safflower, 3 to 80 parts of sargentgloryvine stem, 2 to 80 parts of turmeric, 2 to 80 parts of combined spicebush root, 2 to 70 parts of rhizoma corydalis and 4 to 80 parts of giant knotweed. According to the theory of traditional Chinese medicines, the 10 traditional Chinese medicines are scientifically combined with the modern pharmaceutical research results by adopting dialectical treatment, and have the effects of clearing heat and cooling blood, activating blood and removing stasis, and promoting qi circulation and relieving pain for chronic prostatitis/chronic pelvic pain syndrome.

Description

Traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome and preparation method and application thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome, and a preparation method and application thereof.

Background

Prostatitis has been a common and confusing disease. The disease is frequently seen in adults and rarely occurs in puberty, and Lipsky (1989) reported about 25% of the disease's incidence between 1977 and 1978. The incidence of chronic prostatitis is higher. Prostatitis is a common disorder in adult males. Adult men, which can occur in all ages, almost 50% of men have been affected by prostatitis during a certain period of life. The prostatitis accounts for 8% -25% of the patients in the outpatient urinary surgery. For the therapeutic effect of this disease, most patients are not satisfied and many doctors feel unsmooth in treating prostatitis. At present, it has been recognized that prostatitis is not a disease but has a respective unique form of syndrome, which has a unique cause, clinical characteristics and outcome. So that only an accurate diagnosis of them and the administration of appropriate therapeutic measures is possible with good results.

Drach detected 10ml of initial urine before prostate massage (voided bladder one, VB 1), 10ml of mid-stream urine (voided tbladdm two, VB 2), 10ml of prostate massage fluid (expressed prostatic secretion, EPS) and 10ml of post-prostate massage urine (voided bladder three, VB 3) according to the "four-cup method" proposed by Mearea-Stamey for localized diagnosis of lower urinary tract bacterial infections. Prostatitis is classified into four specimens according to the number of white blood cells and the bacterial culture result: acute bacterial prostatitis (actute bacterial prostatitis, ABP), chronic bacterial prostatitis (chronic bacterial prostatitis, CBP), chronic non-bacterial prostatitis (chronic nonbacterial prostatitis, CNBP), prostatodynia (PD). The dragch classification embodies the recognition that infection is the primary cause of prostatitis, and is the first canonical classification of prostatitis, called the traditional classification. However, prostatodynia is a relatively ambiguous concept, and there are also unknown or undetected diseases associated with prostatodynia, and this classification is not accurate enough.

The national institutes of health (national institutes of health, NIH) developed a new taxonomy in 1995 based on the basic and clinical study of prostatitis: type I corresponds to ABP in traditional classification, type II corresponds to CBP in traditional classification, type III corresponds to CNBP in traditional classification (chronic nonbacterial prostatitis ) in chronic prostatitis/chronic pelvic pain syndrome (chronic prostatitis/chronic pelvic pain syndromes, CP/CPPS), type III is divided into inflammatory IIIA and noninflammatory IIIB subtypes. Type iv, asymptomatic prostatitis (asymptomatic inflammatory prostatitis, AIP). The international cooperative network for prostatitis (international prostatitis collaborative network, IPCN) in 1998 officially approved new classification of NIH after 3 years of clinical study and application of NIH classification. This is a currently clinically accepted method of classifying prostatitis. Among them, chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS, type iii) is the most common type of prostatitis, accounting for about more than 90% of chronic prostatitis. Is mainly manifested by long-term and repeated pelvic region pain or discomfort, and the duration exceeds 3 months, and can be accompanied by urination symptoms and sexual dysfunction with different degrees, which seriously affect the life quality of patients. This type can be subdivided into two subtypes, IIIA (inflammatory CPPS) and IIIB (non-inflammatory CPPS).

The etiology of CP/CPPS is relatively complex and the pathogenesis has not been fully elucidated so far, and therefore there is no clear therapeutic regimen, mostly empirical. The therapeutic objectives are mainly pain relief, symptom improvement of urination and quality of life improvement. The three most commonly used drugs in clinic are antibiotics, alpha receptor blockers and nonsteroidal anti-inflammatory analgesics, and other therapeutic methods are M receptor blockers, botanical preparations, traditional Chinese medicines, antidepressants, anxiolytics, prostate massage, biofeedback and hyperthermia. The single treatment method has unsatisfactory effect, and mainly adopts one treatment method and is simultaneously assisted with comprehensive treatment of other treatment methods. The IIIA type recommends application of antibiotics for 2-4 weeks, and simultaneously application of alpha receptor blockers, non-steroidal anti-inflammatory analgesics, M receptor blockers and plant preparations. The traditional Chinese medicine, prostate massage and other means are selected as auxiliary treatment. IIIB recommends the use of alpha blockers as the primary (12 weeks), non-steroidal anti-inflammatory analgesics, botanical preparations, M receptor blockers and prostate massage as the adjunct, if necessary for psychotherapy and antidepressants and anxiolytics.

In classical books of traditional Chinese medicine, although there is no specific description of the disease, the manifestations are characterized by pain and abnormal urination at the lower abdomen, perineum and lumbosacral region, so they are classified into "lumbago", "abdominal pain", "stranguria" and "uroschesis". In combination with the knowledge of the physician in the past, it is generally considered that the pathogenesis of the disease is mainly in six aspects of dampness, heat, cold, stasis, depression and deficiency, and the excessive cold and heat, deficiency and excess are mixed as the patients.

In view of the current shortages of treating CP/CPPS in traditional chinese and western medicine, the current chinese patent medicines for treating CP/CPPS on the market are basically all marketed before the determination of the disease name, and the description of the indication of the instruction is not specifically directed to the disease. Many clinically effective decoction prescriptions in real world treatment cannot be developed into new traditional Chinese medicines due to the problem of pharmacy. Therefore, a medicine for treating CP/CPPS with obvious curative effect and low adverse reaction is needed at present.

Disclosure of Invention

In order to overcome the defects of poor treatment effect and drug resistance in the prior art and make up for the defects of compatibility of the prior art rules, the inventor provides a prescription suitable for developing a new traditional Chinese medicine according to the results of the drug property optimization study of the new medicine so as to solve the problem that the new traditional Chinese medicine for CP/CPPS has not been marketed for a long time.

The invention aims to provide a traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome, which is prepared by dialectical compatibility of a formula aiming at pathogenesis of male reproductive health and has the effects of clearing heat, cooling blood, promoting blood circulation, removing blood stasis, promoting qi circulation and relieving pain. The invention also aims at providing a preparation method of the traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome. It is still another object of the present invention to provide the pharmaceutical use of the above-mentioned Chinese medicinal composition for preventing and/or treating chronic prostatitis/chronic pelvic pain syndrome.

In order to achieve the above purpose, the present invention adopts the following technical scheme.

In one aspect, the invention provides a traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome, which is prepared from the following raw materials: bupleurum, radix trichosanthis, angelica, peach kernel, safflower, sargentgloryvine stem, turmeric, combined spicebush root, rhizoma corydalis and giant knotweed.

Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 2 to 100 parts of bupleurum, 2 to 100 parts of radix trichosanthis, 1 to 80 parts of angelica, 1 to 80 parts of peach kernel, 2 to 120 parts of safflower, 3 to 80 parts of sargentgloryvine stem, 2 to 80 parts of turmeric, 2 to 80 parts of combined spicebush root, 2 to 70 parts of rhizoma corydalis and 4 to 80 parts of giant knotweed.

Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 3 to 80 parts of bupleurum, 3 to 80 parts of radix trichosanthis, 2 to 50 parts of angelica, 2 to 50 parts of peach kernel, 2 to 60 parts of safflower, 3 to 60 parts of sargentgloryvine stem, 4 to 60 parts of turmeric, 2 to 50 parts of combined spicebush root, 2 to 60 parts of rhizoma corydalis and 4 to 60 parts of giant knotweed.

More preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5 parts of bupleurum, 5 parts of radix trichosanthis, 2 parts of angelica, 2 parts of peach kernel, 2 parts of safflower, 4 parts of sargentgloryvine stem, 5 parts of turmeric, 2 parts of combined spicebush root, 4 parts of rhizoma corydalis and 4 parts of giant knotweed.

Aiming at the pathogenesis characteristics of chronic prostatitis pelvic pain syndrome liver meridian stasis, the invention treats the legislation of clearing heat, cooling blood, promoting blood circulation, removing blood stasis, promoting qi circulation and relieving pain. In the recipe, bupleurum root is used as guiding drug, soothing liver and regulating qi, and qi and blood flow; radix Trichosanthis has effects of clearing heat, purging pathogenic fire, nourishing yin, and moistening dryness; the two drugs are combined together to achieve the effect of ascending and descending to dispel stasis, and are all monarch drugs. Dang Gui, tao ren and hong Hua have the actions of activating blood and resolving stasis, and relieving swelling and pain, and they are ministerial drugs. Caulis Sargentodoxae has effects of clearing heat and detoxicating, dispelling pathogenic wind, promoting blood circulation, relieving pain, removing blood stasis, and resolving hard mass. Turmeric warms and dredges meridians, activates blood and qi, and promotes bile flow. The radix linderae has effects of warming kidney, dispelling cold, promoting qi circulation, relieving pain and detumescence, and can promote qi circulation. Rhizoma corydalis is a wonderful herb for activating blood and dissolving stasis, promoting qi circulation and relieving pain, especially known as analgesic effect. The Li Shizhen has four effects of promoting blood circulation, regulating qi, relieving pain and relieving bowels in the form of "Ben Cao gang mu" and is advocated for treating all pains in the body because it can promote qi stagnation in blood and qi stagnation in qi. The giant knotweed has the effects of clearing away heat and toxic materials, promoting blood circulation, removing blood stasis and the like, and has the effects of resisting bacteria, diminishing inflammation, promoting urination and the like. Caulis Sargentodoxae has effects of dispelling pathogenic wind, promoting blood circulation, and relieving pain, curcuma rhizome can improve pain syndrome due to qi stagnation and blood stasis, has effects of regulating qi and relieving pain, rhizoma corydalis has effects of activating qi-flowing and relieving pain, and rhizoma Polygoni Cuspidati is combined with semen Persicae and radix Angelicae sinensis to moisten blood and dryness, and can prevent qi and blood stasis and resolving pathogenic fire and heat. Qi and blood are involved and pain is relieved. The combination of the medicines can promote blood circulation to remove blood stasis, and can also remove meridian obstruction to relieve pain; it has the actions of soothing liver and promoting qi circulation, and also has the actions of clearing heat and removing turbidity. The prescription has the raw materials and the processing requirements: all meet the requirements of the 2020 edition of Chinese pharmacopoeia.

In another aspect, the present invention provides a method for preparing the above-mentioned Chinese medicinal composition, which comprises the following steps:

(1) Extracting radix bupleuri, radix trichosanthis, peach kernel, safflower, turmeric, combined spicebush root, rhizoma corydalis and giant knotweed with 60v/v% -80v/v% ethanol which is 10-20 times of the medicinal materials in 2-3 times of continuous reflux, each time for 30-90min, mixing the extracting solutions, and filtering;

(2) Taking the residues obtained in the step (1), extracting with water with the mass of 8-15 times of that of the medicinal materials for 1-2 times, each time for 30-60 min, combining the extracting solutions, filtering, and discarding the residues;

(3) Extracting caulis Sargentodoxae and radix Angelicae sinensis for 2-3 times with water 10-20 times of the mass of the medicinal materials for 30-60 min each time, mixing the extractive solutions, filtering under reduced pressure, discarding residues, mixing the extractive solutions with the extractive solution obtained in step (2), and concentrating for 10-20 times;

(4) Mixing the ethanol extract obtained in the step (1) and the concentrated solution obtained in the step (3), regulating the ethanol concentration to be not lower than 60v/v%, standing for more than 8-10h, and respectively collecting supernatant and precipitate;

(5) Concentrating the supernatant obtained in the step (4) to recover ethanol until no ethanol smell exists, passing through weak-polarity macroporous adsorption resin, washing with water, eluting with 60-80 v/v% ethanol, collecting eluent, concentrating and recovering ethanol;

(6) Mixing the precipitate obtained in the step (4) with the concentrated solution obtained in the step (5), sieving with a 200-mesh sieve, and concentrating the filtrate until the relative density is 1.0-1.3; adding adjuvants, mixing, spray drying or vacuum drying to obtain the final product.

According to the preparation method, in the step (6), when the traditional Chinese medicine composition is a powder, the auxiliary material is maltodextrin, and the powder is obtained after conventional spray drying.

According to the preparation method, in the step (6), when the traditional Chinese medicine composition is a wine agent, the auxiliary materials are base wine (the ethanol content of the white wine is about 50-60 v/v%), and the wine agent is obtained after blending and filtering.

In still another aspect, the present invention provides an application of the above-mentioned Chinese medicinal composition in preparing a medicament for preventing and/or treating chronic prostatitis/chronic pelvic pain syndrome; preferably, the chronic prostatitis/pelvic pain syndrome is chronic prostatitis/pelvic pain syndrome type III.

The invention has the beneficial effects that:

the traditional Chinese medicinal materials of the traditional Chinese medicinal composition exert the medicinal effects together according to the principle of monarch, minister, assistant and guide. The composition can be taken at a conventional dosage, can also be matched with other products for treating III type chronic prostatitis/pelvic pain syndrome, has reduced side effects and high safety, achieves the synergistic effect of medicaments in the aspects of tonifying kidney and replenishing vital essence, clearing heat and promoting diuresis, activating blood circulation and dissolving stasis, dredging collaterals and relieving pain, soothing liver and promoting qi circulation, and brings good news to vast male CNP patients.

Compared with the prior art, the traditional Chinese medicine composition has the characteristics of treating the pathogenesis of the chronic prostatitis/pelvic pain syndrome with the syndrome of stagnation of turbid damp-heat and blockage of the essence orifices, and is used for treating the legislation of clearing heat and cooling blood, promoting blood circulation and removing blood stasis, promoting qi circulation and relieving pain. The male rat efficacy research data show that the traditional Chinese medicine composition can obviously improve prostate tissue IL-6, IL-8, white blood cell count, lecithin small body density level and rat prostate index, and shows that the traditional Chinese medicine composition can restore the prostate function of rats.

The prescription is prepared by optimizing the evaluation of the drug property developed by new drugs and then fixing the new drugs through clinical verification, can ensure that various active ingredients such as saikosaponin, polygonin, emodin, berberine, chlorogenic acid, rutin (rutin), lindera alcohol, linalool and the like in the raw materials are completely extracted, simultaneously, the daily dosage of the extract is reduced, the drug hygroscopicity is reduced, the process requirements of different preparations can be met, the quality of the preparation products is stable and controllable, the use by target groups is convenient, and the compliance of long-term administration is improved. Is more suitable for developing new medicines than the decoction prescription used in the past. Clinical verification shows that the medicine has obvious curative effect and no untoward effect. The invention is expected to solve the problem that Chinese medicine for CNP/CPPS has not been marketed for a long time.

Drawings

FIG. 1 shows the results of HE staining pathology of prostate tissue of Experimental example 5 (x 200), wherein A is a sham surgery group; B. a model group; C. a positive drug group; D. example 5, the arrowed portions of the graph show the changes in infiltration of interstitial inflammatory cells in the luminal gland in different groups of prostate tissue.

Detailed Description

In order to further illustrate the present invention, the following examples are provided to illustrate a Chinese medicinal composition, its preparation method and its application in treating chronic prostatitis III/chronic pelvic pain syndrome, and the scope of the present invention is not limited by the following examples. The following description is made in connection with the specific embodiments.

Unless otherwise specifically indicated, the various raw materials, reagents, instruments, equipment and the like used in the present invention are commercially available or may be prepared by existing methods.

Example 1A Chinese medicinal composition for treating chronic prostatitis III/chronic pelvic pain syndrome is prepared by the following steps:

(1) Adding 6g of bupleurum, 6g of radix trichosanthis, 3g of peach kernel, 6g of safflower, 6g of turmeric, 6g of combined spicebush root, 6g of rhizoma corydalis and 12g of giant knotweed, adding 510ml of 70v/v% ethanol, soaking for 30min, continuously reflux-extracting for 2 times, 60min each time, filtering, extracting filter residues for 2 times by using the same method of 510ml of 70v/v% ethanol solution, merging 3 times of filtrate, and filtering under reduced pressure to obtain 1000ml of filtrate;

(2) Extracting the residue obtained in the step (1) with purified water for 2 times, adding 600ml of water each time, decocting for 30min, mixing the extractive solutions, discarding the residue, and filtering under reduced pressure to obtain 870ml of filtrate;

(3) Adding 9g of sargentgloryvine stem and 3g of Chinese angelica into 120ml of purified water, soaking for 30min, decocting for 30min, filtering, extracting filter residues with 120ml of purified water for 2 times in the same way, mixing 3 times of filtrate, discarding residues, and filtering under reduced pressure to obtain 200ml of filtrate;

(4) Combining the filtrates obtained in the steps (2) and (3), concentrating under reduced pressure at-0.06 Mpa and 60 ℃ to 500ml, adding the filtrate obtained in the step (1) into the concentrated solution, adding 300ml of 95v/v% ethanol, standing overnight, centrifuging at 3000rpm for 10min, and collecting supernatant and precipitate respectively;

(5) Recovering ethanol from the supernatant obtained in step (4) under reduced pressure of-0.06 Mpa at 60deg.C, concentrating to 300ml, purifying with D101 macroporous adsorbent resin, washing with water to colorless, eluting with 80v/v% ethanol 500ml, collecting eluate, recovering ethanol under reduced pressure of-0.08 Mpa at 60deg.C, and concentrating to obtain soft extract;

(6) Mixing the precipitate obtained in step (4) with the soft extract obtained in step (5), drying under reduced pressure of-0.085 Mpa at 60deg.C, pulverizing, and sieving with 60 mesh sieve.

Example 2A Chinese medicinal composition for treating chronic prostatitis III/chronic pelvic pain syndrome is prepared by the following steps:

(1) Taking 300g of bupleurum, 300g of radix trichosanthis, 240g of peach kernel, 360g of safflower, 240g of turmeric, 240g of combined spicebush root, 210g of rhizoma corydalis and 240g of giant knotweed, adding 70v/v% ethanol 22L, soaking for 30min, continuously reflux-extracting for 60min each time, filtering, extracting filter residues for 2 times by a 70v/v% ethanol solution 22L method, combining 3 times of filtrate, and filtering under reduced pressure to obtain 38L of filtrate;

(2) Extracting the residue obtained in the step (1) with purified water for 2 times, adding 20L of water each time, decocting for 60min, mixing the extractive solutions, discarding the residue, and filtering under reduced pressure to obtain 36L of filtrate;

(3) Taking 240g of sargentgloryvine stem and 240g of Chinese angelica, adding 5L of purified water, soaking for 30min, decocting for 60min, filtering, extracting filter residues respectively with 5L of purified water for 2 times by the same method, combining 3 times of filtrate, discarding residues, and filtering under reduced pressure to obtain 8.6L of filtrate;

(4) Combining the filtrates obtained in the steps (2) and (3), concentrating under reduced pressure at-0.06 Mpa and 60 ℃ to 20L, adding the filtrate obtained in the step (1) into the concentrated solution, adding 5L of 95v/v% ethanol, standing overnight, centrifuging at 3000rpm for 10min, and collecting supernatant and precipitate respectively;

(5) Recovering ethanol from the supernatant obtained in step 4) under reduced pressure of-0.06 Mpa at 60deg.C, concentrating to 4L, purifying with D101 macroporous adsorbent resin, washing with water to colorless, eluting with 80v/v% ethanol 2L, collecting eluate, recovering ethanol under reduced pressure of-0.08 Mpa at 60deg.C, and concentrating to obtain soft extract;

Example 3A Chinese medicinal composition for treating chronic prostatitis III/chronic pelvic pain syndrome is prepared by the following steps:

(1) Taking 9g of bupleurum, 9g of radix trichosanthis, 6g of peach kernel, 6g of safflower, 12g of turmeric, 6g of combined spicebush root, 12g of rhizoma corydalis and 12g of giant knotweed, adding 720mL of 70% ethanol, soaking for 30min, continuously reflux-extracting for 60min each time, filtering, extracting filter residues for 2 times by using the same method of 720mL of 70% ethanol solution, combining 3 times of filtrate, and filtering under reduced pressure to obtain 1300mL of filtrate;

(2) Extracting the residue obtained in the step (1) with purified water for 2 times, adding 720mL of water each time, decocting for 60min, mixing the extractive solutions, discarding the residue, and filtering under reduced pressure to obtain 1200mL of filtrate;

(3) Taking 9g of sargentgloryvine stem and 6g of Chinese angelica, adding 150mL of purified water, soaking for 30min, decocting for 60min, filtering, extracting filter residues respectively with 150mL of purified water for 2 times by the same method, combining 3 times of filtrate, discarding residues, and filtering under reduced pressure to obtain 260mL of filtrate;

(4) Combining the filtrates obtained in the steps (2) and (3), concentrating under reduced pressure at-0.06 Mpa and 60 ℃ to 400mL, adding the filtrate obtained in the step (1) into the concentrated solution, adding 600mL of 95% ethanol, standing overnight, centrifuging at 3000rpm for 10min, and collecting supernatant and precipitate respectively;

(5) Recovering ethanol from the supernatant obtained in step 4) under reduced pressure of-0.06 Mpa at 60deg.C, concentrating to 300mL, purifying with D101 macroporous adsorbent resin, washing with water to colorless, eluting with 80% ethanol 2000mL, collecting eluate, recovering ethanol under reduced pressure of-0.08 Mpa at 60deg.C, and concentrating to obtain soft extract;

Example 4A Chinese medicinal composition for treating chronic prostatitis III/chronic pelvic pain syndrome is prepared by the following steps:

(1) Taking 240g of bupleurum, 240g of radix trichosanthis, 150g of peach kernel, 180g of safflower, 180g of turmeric, 150g of combined spicebush root, 180g of rhizoma corydalis and 180g of giant knotweed, adding 15L of 70v/v% ethanol, soaking for 30min, continuously reflux-extracting for 60min each time, filtering, extracting filter residues for 2 times by using a 15L method of 70v/v% ethanol solution, merging 3 times of filtrate, and filtering under reduced pressure to obtain 28L of filtrate;

(2) Extracting the residue obtained in the step (1) with purified water for 2 times, adding 13L of water each time, decocting for 60min, mixing the extractive solutions, discarding the residue, and filtering under reduced pressure to obtain 22L of filtrate;

(3) 180g of sargentgloryvine stem and 150g of Chinese angelica are taken, 3.3L of purified water is added, soaked for 30min, decocted for 60min, filtered, and the filter residues are respectively extracted for 2 times by 3.3L of purified water in the same way, the 3 times of filtrate are combined, the medicine residues are discarded, and the filtrate is subjected to reduced pressure filtration to obtain 3.6L of filtrate;

(4) Combining the filtrates obtained in the steps (2) and (3), concentrating under reduced pressure at-0.06 Mpa and 60 ℃ to 3.6L, adding the filtrate obtained in the step (1) into the concentrated solution, adding 1.8L of 95v/v% ethanol, standing overnight, centrifuging at 3000rpm for 10min, and collecting supernatant and precipitate respectively;

(5) Recovering ethanol from the supernatant obtained in the step (4) under reduced pressure of-0.06 Mpa at 60 ℃, concentrating to 0.9L, passing through D101 macroporous adsorption resin, purifying and washing with water to colorless, eluting with 80v/v% ethanol 2L, collecting eluate, recovering ethanol under reduced pressure of-0.08 Mpa at 60 ℃, and concentrating to thick paste;

Example 5A Chinese medicinal composition for treating chronic prostatitis III/chronic pelvic pain syndrome is prepared by the following steps:

(1) Taking 30g of bupleurum, 30g of radix trichosanthis, 12g of peach kernel, 12g of safflower, 30g of turmeric, 12g of combined spicebush root, 24g of rhizoma corydalis and 24g of giant knotweed, adding 1.74L of 70v/v% ethanol, soaking for 30min, continuously reflux-extracting for 60min each time, filtering, extracting filter residues for 2 times by a 1.74L method of 70v/v% ethanol solution, combining 3 times of filtrate, and filtering under reduced pressure to obtain 3L of filtrate;

(2) Extracting the residue obtained in the step (1) with purified water for 2 times, each time with 1.74L of water, decocting for 60min, mixing the extractive solutions, discarding the residue, and filtering under reduced pressure to obtain 3L of filtrate;

(3) Taking 24g of sargentgloryvine stem and 12g of Chinese angelica, adding 0.4L of purified water, soaking for 30min, decocting for 60min, filtering, extracting filter residues respectively with 0.4L of purified water for 2 times in the same way, mixing 3 times of filtrate, discarding residues, and filtering under reduced pressure to obtain 0.8L of filtrate;

(4) Combining the filtrates obtained in the steps (2) and (3), concentrating under reduced pressure at-0.06 Mpa and 60 ℃ to 1L, adding the filtrate obtained in the step (1) into the concentrated solution, adding 1L of 95v/v% ethanol, standing overnight, centrifuging at 3000rpm for 10min, and collecting supernatant and precipitate respectively;

(5) Recovering ethanol from the supernatant obtained in step (4) under reduced pressure of-0.06 Mpa at 60deg.C, concentrating to 2L, purifying with D101 macroporous adsorbent resin, washing with water to colorless, eluting with 80v/v% ethanol, collecting eluate, recovering ethanol under reduced pressure of-0.08 Mpa at 60deg.C, and concentrating to obtain soft extract;

Experimental analysis

Experimental example 1

Experimental materials

1. Experimental animals: rats were randomly grouped by body weight into sham surgery, model, positive drug, dosing groups, 4 groups of 10 animals each. 7 week old male SD rats (SPF grade, 40) 220-250g.

2. Dosage of administration: the administration group of the present invention: example 5, the dose of the drug to rats was 11.87g crude drug/kg body weight, positive drug group: the rat dose of Qianliekang tablet (0.57 g/tablet, national drug standard Z33020303, zhejiang Kang Enbei pharmaceutical Co., ltd.) was 0.5g/kg body weight, and the dose volume was 0.1ml/10g body weight. The model and sham groups were gavaged with equal volumes of saline 1 time per day for 30 consecutive days.

(II) Experimental methods

1. The molding method comprises the following steps: intraperitoneal injection of 100 g.L on the day of molding operation ^-1 3mL kg of chloral hydrate ^-1 After the rats had been anesthetized, an incision of about 1cm was made longitudinally in the lower abdomen, exposing the dorsal prostate of the bladder and the seminal vesicles. Sham rats were immediately sutured to muscle skin; carrageenan rats were given 10 g.L ^-1 Carrageenan saline was injected into the bilateral seminal vesicles at 0.05mL per side, suturing the muscle skin.

2. Mechanical stimulation foot-shortening threshold (paw withdrawal threshold, PWT): rats were placed in a translucent plexiglas cage and hind limb midplantar areas were stimulated with a series of standardized fine fibers (Von Frey fibers), and the fibers were bent into an S-shape (representing mechanical stimulation 1-50 g) with slight cilia bending as a standard of complete stress for 6-8S, and the hind limb plantar responses were observed. Von Frey filaments were used sequentially in gram order (2, 4, 6, 8, 10, 15, 26 g), with each stimulus lasting 2s, 15s intervals, 5 consecutive times. The lowest Von Frey wire gram number that can cause 3/5 leg lifts is defined as PWT. In the early experiments we found that cox2 mediated sensitization of spinal cord relief pain began to increase in rats 6 weeks after molding, and PWT was measured 6 weeks after molding.

3. Prostate index test: after 30d of continuous administration, the rats were fasted without water forbidding for 12h, the mass was weighed, the prostate tissue was dissected, physiological saline was washed, the filter paper was sucked with excess water, the wet mass was weighed by an electronic balance, the prostate index was calculated, and the formula was prostate index= [ wet mass of prostate/mass of rat ] ×100%, swelling rate= [ (inflamed rat prostate index-sham rat prostate index)/sham rat prostate index ] ×100%, swelling inhibition rate= [ (model group swelling rate-drug group swelling rate)/model group swelling rate ] ×100%.

4. Prostate tissue IL-6, IL-8 level detection: taking left prostate tissue of a rat, weighing the mass, adding 2 times of physiological saline for homogenizing, standing, centrifuging for 15min at 3 000r/min, and detecting the IL-6 and IL-8 levels in the prostate tissue homogenate by adopting an ELISA method.

5. White blood cell count, lecithin bulk density level: whole blood samples were collected and white blood cell counts (WBCs) were measured in each group of rat whole blood using a three-class blood cell analyzer.

Total number of white blood cells/l=total number of white blood cells in 4 large squares×50×10 ⁶ 。

Another prostate fluid was selected and placed on a slide, covered with a glass slide, and examined under a microscope for lecithin bulk density. Average scoring standard of lecithin small body density, namely, the lecithin small body is full of vision, and 4 minutes; 3/4 field of view of lecithin small body, 3 minutes; lecithin small body 1/2 visual field, 2 minutes; lecithin small body 1/4 visual field, 1 minute.

(III) results of experiments

1. Effects on rat body mass, prostate wet mass, and prostate index

The quality comparison of the rat bodies of each group shows that the difference has no statistical significance (P is more than 0.05), and the modeling and the administration have no obvious influence on the quality increase of the rat bodies. By comparing with the sham operation group, the wet quality of the prostate and the index of the prostate of the rats in the model group are increased, and the pain valve is obviously reduced (P is less than 0.05), which indicates that the model is successfully manufactured; compared with the model group, the positive medicine group and the rat prostate wet quality, the prostate index and the pain valve of the invention in the example 5 all change obviously (P < 0.05); by comparison with the positive drug, the prostate wet quality, prostate index and pain valve of the rats of example 5 of the present invention are significantly better than those of the positive drug group (P < 0.05), as detailed in Table 1.

Table 1: effects of the inventive group on prostate index in rats

Note that: in contrast to the sham-operated group, ^* p<0.05; in contrast to the set of models, ^# p<0.05; in contrast to the positive drug group, ^§ p<0.05。

2. effects of the present invention on rat prostate tissue IL-6, IL-8, white blood cell count and lecithin body density levels: compared with the sham operation group, the prostate tissue IL-6 and IL-8 levels and the white blood cell count of the model group are increased (P < 0.05), and the density of lecithin bodies is reduced (P < 0.05), which indicates that the modeling is successful; compared with the model group, the positive medicine group, the rat prostate tissue IL-6, IL-8 and white blood cell count of the example 5 group are reduced, and the density of lecithin bodies is obviously increased (P is less than 0.05); compared with the positive drug group, the prostate tissue IL-6, IL-8 levels and white blood cell count of the rats in the example 5 group were significantly decreased (P < 0.05), and the lecithin body density was significantly increased (P < 0.05), as shown in Table 2.

Table 2: the effects of the group of the present invention on the plasma tissue IL-6, IL-8, white blood cell count, and lecithin body Density levels in rats

Note that: in contrast to sham surgery group, ×p<0.05; in contrast to the set of models, ^# p<0.05; in contrast to the positive drug group, ^§ p<0.05。

(IV) conclusion of experiments

The test results show that: in the chronic prostatitis experiments of rats, IL-6, IL-8 and white blood cell count are all obviously increased, and lecithin body density is obviously reduced compared with a control group sham operation group, so that modeling is successful. Compared with the model group, the positive medicine group and the prostatitis index of the embodiment 5 of the invention are obviously improved, and the effect of the embodiment 5 of the invention is most obvious. The comparative analysis with the positive drug group shows that the data of prostatitis of rats after 30 days of administration shows that the data of the prostate of the group 5 of the invention is obviously changed and has a certain protection effect, which indicates that the group of the invention can restore the prostate function of rats.

Experimental example 2

Experimental materials

1. Experimental animals: rats were randomly grouped by body weight into sham groups, model groups, example 1, example 2, example 3, example 4, and example 5, 7 total, 10 animals per group. 7 week old male SD rats (SPF grade, 70), 220-250g.

2. Dosage of administration: the rats of each of examples 1, 2, 3, 4 and 5 were administered at an amount of 11.87g crude drug/kg body weight, and the drug was administered by re-gavage at a volume of 0.1ml/10g body weight at a concentration corresponding to the amount of the drug administered prior to administration. The model and sham groups were gavaged with equal volumes of saline 1 time per day for 30 consecutive days.

(II) Experimental methods

1, a molding method: the same as in experimental example 1.

2. Mechanical stimulation foothold (paw withdrawal threshold, PWT), prostate index test, prostate tissue IL-6, IL-8 level test, white blood cell count, lecithin body density level: the same as in experimental example 1.

(III) results of experiments

1. Effects on rat body mass, prostate wet mass, and prostate index

The quality comparison of the rat bodies of each group shows that the difference has no statistical significance (P is more than 0.05), and the modeling and the administration have no obvious influence on the quality increase of the rat bodies. By comparing with the sham operation group, the wet quality of the prostate and the index of the prostate of the rats in the model group are increased, and the pain valve is obviously reduced (P is less than 0.05), which indicates that the model is successfully manufactured; the rat prostate wet mass, prostate index, pain valve of examples 1, 2, 3, 4 and 5 all varied significantly (P < 0.05) compared to the model group; the rat prostate wet mass, prostate index, and pain valve of example 5 of the present invention are superior to those of the other 4 examples, as detailed in table 3.

Table 3: effects of the inventive group on prostate index in rats

Note that: in contrast to the sham-operated group, ^* p<0.05; in contrast to the set of models, ^# p<0.05。

2. effects of the present invention on rat prostate tissue IL-6, IL-8, white blood cell count and lecithin body density levels: compared with the sham operation group, the prostate tissue IL-6 and IL-8 levels and the white blood cell count of the model group are increased (P < 0.05), and the density of lecithin bodies is reduced (P < 0.05), which indicates that the modeling is successful; compared to the model group, the rat prostate tissues IL-6, IL-8 and white blood cell count of example 1, example 2, example 3, example 4 and example 5 decreased, and the lecithin body density increased significantly (P < 0.05); the rat prostate tissue IL-6, IL-8 levels and white blood cell counts were reduced to varying degrees (P < 0.05) for example 1, example 2, example 3, example 4 and example 5, and the lecithin body densities were significantly increased (P < 0.05) compared to the model group, as detailed in Table 4.

Table 4: the effects of the group of the present invention on the plasma tissue IL-6, IL-8, white blood cell count, and lecithin body Density levels in rats

Note that: in contrast to sham surgery group, ×p<0.05; in contrast to the set of models, ^# p<0.05。

(IV) conclusion of experiments

The test results show that: in the chronic prostatitis experiments of rats, IL-6, IL-8 and white blood cell count are all obviously increased, and lecithin body density is obviously reduced compared with a control group sham operation group, so that modeling is successful. The prostatitis criteria of examples 1, 2, 3, 4 and 5 were all significantly improved compared to the model group, with example 5 of the present invention being most effective. Compared with the model group, the data of prostatitis of rats after 30 days of administration show that the data of the prostate of the group 5 of the invention is obviously changed and has a certain protection effect, which indicates that the group of the invention can restore the prostate function of rats.

Experimental example 3

Experimental materials

1. Experimental animals: rats were randomly grouped by body weight into sham, model, a, B, C and D groups, 6 total, 10 animals per group. 7 week old male SD rats (SPF grade, 60) 220-250g.

2. Test grouping: the specific components of each group of medicines are as follows:

group A: taking 30g of cimicifuga foetida, 30g of radix trichosanthis, 12g of peach kernel, 12g of safflower, 30g of turmeric, 12g of combined spicebush root, 24g of rhizoma corydalis, 24g of giant knotweed, 24g of sargentgloryvine stem and 12g of Chinese angelica;

group B comprises radix bupleuri 30g, radix Puerariae 30g, semen Persicae 12g, flos Carthami 12g, rhizoma Curcumae Longae 30g, radix Linderae 12g, rhizoma corydalis 24g, rhizoma Polygoni Cuspidati 24g, caulis Sargentodoxae 24g, and radix Angelicae sinensis 12g;

group C comprises bupleuri radix 30g, trichosanthis radix 30g, semen Persicae 12g, carthami flos 12g, herba Houttuyniae 30g, radix Linderae 12g, rhizoma corydalis 24g, rhizoma Polygoni Cuspidati 24g, caulis Sargentodoxae 24g, and radix Angelicae sinensis 12g;

group D (example 5) comprises radix bupleuri 30g, radix Trichosanthis 30g, semen Persicae 12g, flos Carthami 12g, rhizoma Curcumae Longae 30g, radix Linderae 12g, rhizoma corydalis 24g, rhizoma Polygoni Cuspidati 24g, caulis Sargentodoxae 24g, and radix Angelicae sinensis 12g;

3. dosage of administration: the dosage of rats in group A, group B, group C and group D is 11.87g crude drug/kg body weight; before administration, the medicine is prepared into corresponding concentration and then is subjected to gastric administration, and the administration volume is 0.1ml/10g of body weight. The model and sham groups were gavaged with equal volumes of saline 1 time per day for 30 consecutive days.

(II) Experimental methods

1. The molding method comprises the following steps: same as in Experimental example 1

(III) results of experiments

1. Effects on rat body mass, prostate wet mass, and prostate index

The quality comparison of the rat bodies of each group shows that the difference has no statistical significance (P is more than 0.05), and the modeling and the administration have no obvious influence on the quality increase of the rat bodies. By comparing with the sham operation group, the wet quality of the prostate and the index of the prostate of the rats in the model group are increased, and the pain valve is obviously reduced (P is less than 0.05), which indicates that the model is successfully manufactured; rats of group a, group B, group C and group D (example 5) had significantly changed prostate wet mass, prostate index and pain valve (P < 0.05) compared to the model group; the wet mass, prostate index, pain valve of the rat in example 5 of the present invention are superior to those in group a, group B and group C, as detailed in table 5.

Table 5: effects of the inventive group on prostate index in rats

2. effects of the present invention on rat prostate tissue IL-6, IL-8, white blood cell count and lecithin body density levels: compared with the sham operation group, the prostate tissue IL-6 and IL-8 levels and the white blood cell count of the model group are increased (P < 0.05), and the density of lecithin bodies is reduced (P < 0.05), which indicates that the modeling is successful; rat prostate tissue IL-6, IL-8 and white blood cell count decreased and lecithin body density increased significantly (P < 0.05) in group a, group B, group C and group D compared to model group; compared with the model group, the prostate tissue IL-6, IL-8 levels and white blood cell count of rats in group A, group B, group C and group D were decreased to different degrees (P < 0.05), and the density of lecithin bodies was significantly increased (P < 0.05), as shown in Table 6.

Table 6: the effects of the group of the present invention on the plasma tissue IL-6, IL-8, white blood cell count, and lecithin body Density levels in rats

(IV) conclusion of experiments

The test results show that: in the chronic prostatitis experiments of rats, IL-6, IL-8 and white blood cell count are all obviously increased, and lecithin body density is obviously reduced compared with a control group sham operation group, so that modeling is successful. The prostatitis index of group A, group B, group C and group D were all significantly improved compared to the model group, with the effect of example 5 (group D) of the present invention being most pronounced. The comparative analysis with the model group shows that the prostatitis data of the rat after 30 days of administration show that the prostate data of the group 5 (group D) of the invention is obviously changed and has a certain protection effect, which indicates that the group of the invention can restore the prostate function of the rat.

Experimental example 4

Experimental materials

1. Experimental animals: rats were randomly grouped by body weight into sham, model, a, B and C groups, 5 groups of 10 animals each. 7 week old male SD rats (SPF grade, 50) 220-250g.

group a (patent CN1814074 a): taking 396.3g of red sage root, 139g of red peony root, 69.8g of herba lycopi, 46.5g of safflower, 46.5g of peach kernel, 46.5g of rhizoma corydalis, 115.7g of cowherb seed, 23.3g of honeysuckle, 46.5g of turmeric, 23.3g of poria cocos, 23.3g of rhizoma alismatis and 23.3g of jujube;

group B (CN 106474410A) comprises flos Lonicerae 10g, rhizoma Phragmitis 9g, rubi fructus 6g, bulbus Allii Macrostemi 5g, radix Puerariae 5g, semen euryales 7g, rhizoma Dioscoreae 11g, semen Persicae 5g, thallus laminariae 6g, herba Taraxaci 5g, coicis semen 9g, herba Houttuyniae 5g, fructus Alpinae Oxyphyllae 5g, fructus Foeniculi 6g, and flos Chrysanthemi 6g;

group C (example 5) comprises radix bupleuri 30g, radix Trichosanthis 30g, semen Persicae 12g, flos Carthami 12g, rhizoma Curcumae Longae 30g, radix Linderae 12g, rhizoma corydalis 24g, rhizoma Polygoni Cuspidati 24g, caulis Sargentodoxae 24g, and radix Angelicae sinensis 12g;

3. dosage of administration: the dosage of rats in group A, group B and group C is 11.87g crude drug/kg body weight; before administration, the medicine is prepared into corresponding concentration and then is subjected to gastric administration, and the administration volume is 0.1ml/10g of body weight. The model and sham groups were gavaged with equal volumes of saline 1 time per day for 30 consecutive days.

(II) Experimental methods

(III) results of experiments

1. Effects on rat body mass, prostate wet mass, and prostate index

The quality comparison of the rat bodies of each group shows that the difference has no statistical significance (P is more than 0.05), and the modeling and the administration have no obvious influence on the quality increase of the rat bodies. By comparing with the sham operation group, the wet quality of the prostate and the index of the prostate of the rats in the model group are increased, and the pain valve is obviously reduced (P is less than 0.05), which indicates that the model is successfully manufactured; compared with the model group, the prostate wet quality, the prostate index and the pain valve of rats in the group A, the group B and the group C are all obviously changed (P is less than 0.05); the wet mass of the prostate, prostate index, pain valve were superior to those of groups a and B in rats of group C (inventive example 5), as detailed in table 7.

Table 7: effects of the inventive group on prostate index in rats

2. effects of the present invention on rat prostate tissue IL-6, IL-8, white blood cell count and lecithin body density levels: compared with the sham operation group, the prostate tissue IL-6 and IL-8 levels and the white blood cell count of the model group are increased (P < 0.05), and the density of lecithin bodies is reduced (P < 0.05), which indicates that the modeling is successful; compared with the model group, the prostate tissues of rats in the A group, the B group and the C group have reduced IL-6, IL-8 and white blood cell count, and the density of lecithin bodies is obviously increased (P is less than 0.05); compared with the model group, the prostate tissue IL-6, IL-8 levels and white blood cell counts of rats in group A, group B and group C were decreased to different extents (P < 0.05), and the density of lecithin bodies was significantly increased (P < 0.05), as shown in Table 8.

Table 8: the effects of the group of the present invention on the plasma tissue IL-6, IL-8, white blood cell count, and lecithin body Density levels in rats

(IV) conclusion of experiments

The test results show that: in the chronic prostatitis experiments of rats, IL-6, IL-8 and white blood cell count are all obviously increased, and lecithin body density is obviously reduced compared with a control group sham operation group, so that modeling is successful. The prostatitis index of group A, group B and group C were all significantly improved compared to the model group, with the effect of example 5 (group C) of the present invention being most pronounced. The comparative analysis with the model group shows that the prostatitis data of the rat after 30 days of administration show that the prostate data of the group 5 (group C) of the invention is obviously changed and has a certain protection effect, which indicates that the group of the invention can restore the prostate function of the rat.

Experimental example 5

Experimental materials

1. Experimental animals: rats were randomly grouped by body weight into sham surgery groups, model groups, positive drug groups, example 5, 4 groups of 10 animals each. 7 week old male SD rats (SPF grade, 40) 220-250g.

(II) Experimental methods

1. The molding method comprises the following steps: the same as in experimental example 1.

2. Pathological index: the prostate tissues were subjected to conventional embedding and slicing followed by HE staining, and the prostate tissues fixed with 4% formaldehyde solution were taken for each group, and gradient dehydrated and paraffin embedded after 24 hours. Cut pieces (5 μm) were prepared. After conventional dewaxing and dehydration, hematoxylin-eosin staining was observed under an optical microscope.

(III) results of experiments

1. HE staining pathological results of prostate tissue

The results of the HE staining pathology of the prostate tissue are shown in figure 1. From the pathological section it can be seen that: the prostate tissue structure of the false operation group is complete, the limit is clear, the gland cavity is regular, the gland epithelial cells are orderly arranged, and the gland cavity interstitial is infiltrated by a small amount of inflammatory cells. The pathological results of the model group are that the HE staining results of the rat prostate tissue are obviously changed compared with the blank group, the vasodilation congestion in the prostate tissue can be observed, the endocrine in the cavity is reduced, the foam cavity is obviously narrow, the acinus epithelium presents papillary hyperplasia, interstitial loose edema and fibrosis, and a large amount of lymphocyte infiltration is seen around the interstitial space of the gland cavity, so that the model of the rat with prostatitis is successfully replicated. The pathological result of the positive medicine group is that the prostate tissue gland cavity of the rat is enlarged and irregular, the arrangement of gland cavity epithelial cells is disordered, and lymphocyte infiltration is less around the interstitial space of the gland cavity. The pathological result of example 5 was that most of the glandular cavities were structurally complete, but the glandular epithelial cells were not aligned, the basal membrane was recessed into the glandular cavities, and the interstitium was seen as a small inflammatory cell infiltration.

(IV) conclusion of experiments

The results in the rat chronic prostatitis pathology experiment show that: the model group is compared with the false operation group, and the pathological change of the model group is obvious; the positive medicine and the example 5 are respectively compared with the model group, the pathological results of the rat prostate are better improved, and only a small amount of inflammatory cells infiltrate the interstitial space. The pathological results after 30 days of administration show that the group 5 of the invention has obvious pathological image change, and the medicament has a certain degree of protection on the prostatic tissue, which indicates that the group can better improve the prostatic pathological tissue of rats.

Claims

1. A traditional Chinese medicine composition for treating chronic prostatitis/chronic pelvic pain syndrome is prepared from the following raw materials: 2 to 100 parts of bupleurum, 2 to 100 parts of radix trichosanthis, 1 to 80 parts of angelica, 1 to 80 parts of peach kernel, 2 to 120 parts of safflower, 3 to 80 parts of sargentgloryvine stem, 2 to 80 parts of turmeric, 2 to 80 parts of combined spicebush root, 2 to 70 parts of rhizoma corydalis and 4 to 80 parts of giant knotweed.

2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 3 to 80 parts of bupleurum, 3 to 80 parts of radix trichosanthis, 2 to 50 parts of angelica, 2 to 50 parts of peach kernel, 2 to 60 parts of safflower, 3 to 60 parts of sargentgloryvine stem, 4 to 60 parts of turmeric, 2 to 50 parts of combined spicebush root, 2 to 60 parts of rhizoma corydalis and 4 to 60 parts of giant knotweed.

3. The traditional Chinese medicine composition according to claim 1 or 2, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:

5 parts of bupleurum, 5 parts of radix trichosanthis, 2 parts of angelica, 2 parts of peach kernel, 2 parts of safflower, 4 parts of sargentgloryvine stem, 5 parts of turmeric, 2 parts of combined spicebush root, 4 parts of rhizoma corydalis and 4 parts of giant knotweed.

4. A method of preparing the traditional Chinese medicine composition of any one of claims 1 to 3, wherein the method of preparing comprises the steps of:

(1) Extracting bupleuri radix, radix Trichosanthis, semen Persicae, carthami flos, curcuma rhizome, radix Linderae, rhizoma corydalis and rhizoma Polygoni Cuspidati with 60v/v% -80v/v% ethanol of 10-20 times of the materials for 2-3 times under reflux for 30-90min each time, mixing the extractive solutions, and filtering;

(2) Extracting the residues obtained in the step (1) with water with the mass of 8-15 times of that of the medicinal materials for 1-2 times, each time for 30-60 min, combining the extracting solutions, filtering, and discarding the residues;

(4) Mixing the ethanol extract obtained in the step (1) and the concentrated solution obtained in the step (3), regulating the concentration of ethanol to be not lower than 60v/v%, standing for more than 8-10h, and respectively collecting supernatant and precipitate;

5. The preparation method of claim 4, wherein in the step (6), when the traditional Chinese medicine composition is a powder, the auxiliary material is maltodextrin, and the powder is obtained after conventional spray drying.

6. The preparation method of claim 4, wherein in the step (6), when the traditional Chinese medicine composition is a wine agent, the auxiliary material is a base wine, and the wine agent is obtained after blending and filtering, wherein the base wine is white wine with ethanol content of 50-60 v/v%.

7. Use of a traditional Chinese medicine composition according to any one of claims 1 to 3 for the preparation of a medicament for the treatment of chronic prostatitis/pelvic pain syndrome.

8. The use according to claim 7, wherein the chronic prostatitis/pelvic pain syndrome is chronic prostatitis/pelvic pain syndrome of type iii.